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Afatinib Monotherapy in Patients With ERBB-deregulated Metastatic Urothelial Tract Carcinoma After Failure of Platinum Based Chemotherapy (LUX-Bladder 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02780687
Recruitment Status : Completed
First Posted : May 23, 2016
Results First Posted : October 12, 2020
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Urologic Neoplasms
Intervention Drug: Afatinib
Enrollment 42
Recruitment Details This study was a Phase II open label single arm exploratory trial of oral afatinib monotherapy following platinum failure for patients with advanced/metastatic urothelial tract carcinoma with genetic alterations in ERBB receptors.
Pre-assignment Details All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Arm/Group Title Cohort A Cohort B
Hide Arm/Group Description Afatinib monotherapy in patients with urothelial tract carcinoma who progressed after first line of platinum-based chemotherapy and who show mutations in ERBB2 or ERBB3 or amplification in ERBB2 (Erythroblastic leukaemia viral oncogene homolog of the human epidermal growth factor family of receptors). Therapy consists of 40 mg film-coated tablets taken orally once a day continuously. The dose could be reduced to 30 mg or, in a second step, to 20 mg once daily. No dose increase was allowed after a dose reduction. Afatinib monotherapy in patients with urothelial tract carcinoma who progressed after first line of platinum-based chemotherapy and who show EGFR (Epidermal Growth Factor Receptor) amplification. Therapy consists of 40 mg film-coated tablets taken orally once a day continuously. The dose could be reduced to 30 mg or, in a second step, to 20 mg once daily. No dose increase was allowed after a dose reduction.
Period Title: Overall Study
Started 34 8
Completed 0 0
Not Completed 34 8
Reason Not Completed
Adverse Event             1             1
Withdrawal by Subject             2             1
Switched to commercial program (in CTP)             2             0
progressive disease             29             6
Arm/Group Title Cohort A Cohort B Total
Hide Arm/Group Description Afatinib monotherapy in patients with urothelial tract carcinoma who progressed after first line of platinum-based chemotherapy and who show mutations in ERBB2 or ERBB3 or amplification in ERBB2 (Erythroblastic leukaemia viral oncogene homolog of the human epidermal growth factor family of receptors). Therapy consists of 40 mg film-coated tablets taken orally once a day continuously. The dose could be reduced to 30 mg or, in a second step, to 20 mg once daily. No dose increase was allowed after a dose reduction. Afatinib monotherapy in patients with urothelial tract carcinoma who progressed after first line of platinum-based chemotherapy and who show EGFR (Epidermal Growth Factor Receptor) amplification. Therapy consists of 40 mg film-coated tablets taken orally once a day continuously. The dose could be reduced to 30 mg or, in a second step, to 20 mg once daily. No dose increase was allowed after a dose reduction. Total of all reporting groups
Overall Number of Baseline Participants 34 8 42
Hide Baseline Analysis Population Description
The treated set (TS) included all patients who took at least 1 afatinib dose.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 8 participants 42 participants
66.4  (10.3) 70.0  (6.9) 67.1  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 8 participants 42 participants
Female
4
  11.8%
2
  25.0%
6
  14.3%
Male
30
  88.2%
6
  75.0%
36
  85.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 8 participants 42 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
34
 100.0%
8
 100.0%
42
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Biomarker status  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 34 participants 8 participants 42 participants
ERBB2 mutation 8 0 8
ERBB3 mutation 11 0 11
ERBB2 amplification 20 0 20
EGFR amplification 3 8 11
1.Primary Outcome
Title Number of Participants With Progression-free Survival at Six Months (PFS6) in Cohort A
Hide Description Progression-free survival at 6 months for Cohort A was defined as the number of patients who were alive and without disease progression at 24-week tumour assessment. Tumour response was assessed based on local radiological image (Computerised tomography (CT) or Magnetic resonance imaging (MRI)) evaluation by the investigators according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1. Baseline imaging was to be performed within 28 days before afatinib treatment start, if the patient already had a tumour assessment within this timeframe, this test was not repeated. Progression is defined as at least a 20% increase in sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD since the treatment started, together with an absolute increase in the sum of LD of at least 5 millimeter OR The appearance of one or more new lesions.
Time Frame From start of treatment till assesment at week 24.
Hide Outcome Measure Data
Hide Analysis Population Description
The treated set (TS) included all patients who took at least 1 afatinib dose. The aim of the study was to investigate patients with ERBB-deregulated tumours (cohort A), patients with EGFR amplification (cohort B) were therefore not included in the endpoint.
Arm/Group Title Cohort A
Hide Arm/Group Description:
Afatinib monotherapy in patients with urothelial tract carcinoma who progressed after first line of platinum-based chemotherapy and who show mutations in ERBB2 or ERBB3 or amplification in ERBB2 (Erythroblastic leukaemia viral oncogene homolog of the human epidermal growth factor family of receptors). Therapy consists of 40 mg film-coated tablets taken orally once a day continuously. The dose could be reduced to 30 mg or, in a second step, to 20 mg once daily. No dose increase was allowed after a dose reduction.
Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
Without progression/death at 24th week
4
  11.8%
2.Secondary Outcome
Title Number of Participants With Confirmed Objective Response (ORR) in Cohort A
Hide Description Confirmed objective response by investigator review for Cohort A was defined as the number of participants with confirmed complete response (CR, disappearance of all target lesions) or confirmed partial response (PR, at least a 30% decrease in sum of longest diameter (LD) of target lesions, reference is baseline sum LD). Tumour response was assessed based on local radiological image (Computerised tomography (CT) or Magnetic resonance imaging (MRI)) evaluation by the investigators according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1. Baseline imaging was to be performed within 28 days before afatinib treatment start, if the patient already had a tumour assessment within this timeframe, this test was not repeated.
Time Frame Scans every 8 (±1) weeks from start till end of treatment. Afterwards, if discontinuation was not for progression: every 8 (±1) weeks until month 6, every 12 (±2) weeks thereafter. Until documented disease progression, i.e., up to ~ 20 Months.
Hide Outcome Measure Data
Hide Analysis Population Description
The treated set (TS) included all patients who took at least 1 afatinib dose. The aim of the study was to investigate patients with ERBB-deregulated tumours (cohort A), patients with EGFR amplification (cohort B) were therefore not included in the endpoint.
Arm/Group Title Cohort A
Hide Arm/Group Description:
Afatinib monotherapy in patients with urothelial tract carcinoma who progressed after first line of platinum-based chemotherapy and who show mutations in ERBB2 or ERBB3 or amplification in ERBB2 (Erythroblastic leukaemia viral oncogene homolog of the human epidermal growth factor family of receptors). Therapy consists of 40 mg film-coated tablets taken orally once a day continuously. The dose could be reduced to 30 mg or, in a second step, to 20 mg once daily. No dose increase was allowed after a dose reduction.
Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
Objective response
2
   5.9%
3.Secondary Outcome
Title Progression-free Survival (PFS) in Cohort A
Hide Description Progression-free survival was defined as the time (months) from the date of the first afatinib administration to the date of disease progression or death (if the patient died without progression). The date of progression for the primary analyses was determined based on investigator assessment. Tumour response was assessed based on local radiological image (Computerised tomography (CT) or Magnetic resonance imaging (MRI)) evaluation by the investigators according to RECIST version 1.1. Baseline imaging was to be performed within 28 days before afatinib treatment start, if the patient already had a tumour assessment within this timeframe, this test was not repeated. Progression is defined as at least a 20% increase in sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD since the treatment started, together with an absolute increase in the sum of LD of at least 5 millimeter OR The appearance of one or more new lesions.
Time Frame Scans every 8 (±1) weeks from start till end of treatment. Afterwards, if discontinuation was not for progression: every 8 (±1) weeks until month 6, every 12 (±2) weeks thereafter. Until documented disease progression, i.e., up to ~ 20 Months.
Hide Outcome Measure Data
Hide Analysis Population Description
The treated set (TS) included all patients who took at least 1 afatinib dose. The aim of the study was to investigate patients with ERBB-deregulated tumours (cohort A), patients with EGFR amplification (cohort B) were therefore not included in the endpoint.
Arm/Group Title Cohort A
Hide Arm/Group Description:
Afatinib monotherapy in patients with urothelial tract carcinoma who progressed after first line of platinum-based chemotherapy and who show mutations in ERBB2 or ERBB3 or amplification in ERBB2 (Erythroblastic leukaemia viral oncogene homolog of the human epidermal growth factor family of receptors). Therapy consists of 40 mg film-coated tablets taken orally once a day continuously. The dose could be reduced to 30 mg or, in a second step, to 20 mg once daily. No dose increase was allowed after a dose reduction.
Overall Number of Participants Analyzed 34
Median (95% Confidence Interval)
Unit of Measure: Weeks
9.8
(7.9 to 16.0)
4.Secondary Outcome
Title Overall Survival (OS) in Cohort A
Hide Description Overall survival (OS) defined as the time from start of treatment of afatinib until death from any cause.
Time Frame From start of treatment of afatinib until death from any cause, i.e. up to approximately 20 Months.
Hide Outcome Measure Data
Hide Analysis Population Description
The treated set (TS) included all patients who took at least 1 afatinib dose. The aim of the study was to investigate patients with ERBB-deregulated tumours (cohort A), patients with EGFR amplification (cohort B) were therefore not included in the endpoint.
Arm/Group Title Cohort A
Hide Arm/Group Description:
Afatinib monotherapy in patients with urothelial tract carcinoma who progressed after first line of platinum-based chemotherapy and who show mutations in ERBB2 or ERBB3 or amplification in ERBB2 (Erythroblastic leukaemia viral oncogene homolog of the human epidermal growth factor family of receptors). Therapy consists of 40 mg film-coated tablets taken orally once a day continuously. The dose could be reduced to 30 mg or, in a second step, to 20 mg once daily. No dose increase was allowed after a dose reduction.
Overall Number of Participants Analyzed 34
Median (95% Confidence Interval)
Unit of Measure: Weeks
30.1
(17.4 to 47.0)
5.Secondary Outcome
Title Number of Participants With Disease Control (DCR) in Cohort A
Hide Description Disease control was calculated as the number of participants with complete response (CR, disappearance of all target lesions), partial response (PR, at least a 30% decrease in sum of longest diameter (LD) of target lesions, reference is baseline sum LD), or stable disease (SD, neither sufficient shrinkage to qualify for PR, taking as reference the baseline sum of diameters (SoD), nor sufficient increase to qualify for PD (Progression) taking as reference the smallest SoD since the treatment started). Tumour response was assessed based on local radiological image (Computerised tomography (CT) or Magnetic resonance imaging (MRI)) evaluation by the investigators according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1. Baseline imaging was to be performed within 28 days before afatinib treatment start, if the patient already had a tumour assessment within this timeframe, this test was not repeated.
Time Frame Scans every 8 (±1) weeks from start till end of treatment. Afterwards, if discontinuation was not for progression: every 8 (±1) weeks until month 6, every 12 (±2) weeks thereafter. Until documented disease progression, i.e., up to ~ 20 Months.
Hide Outcome Measure Data
Hide Analysis Population Description
The treated set (TS) included all patients who took at least 1 afatinib dose. The aim of the study was to investigate patients with ERBB-deregulated tumours (cohort A), patients with EGFR amplification (cohort B) were therefore not included in the endpoint.
Arm/Group Title Cohort A
Hide Arm/Group Description:
Afatinib monotherapy in patients with urothelial tract carcinoma who progressed after first line of platinum-based chemotherapy and who show mutations in ERBB2 or ERBB3 or amplification in ERBB2 (Erythroblastic leukaemia viral oncogene homolog of the human epidermal growth factor family of receptors). Therapy consists of 40 mg film-coated tablets taken orally once a day continuously. The dose could be reduced to 30 mg or, in a second step, to 20 mg once daily. No dose increase was allowed after a dose reduction.
Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
17
  50.0%
No
17
  50.0%
6.Secondary Outcome
Title Duration of Disease Control in Cohort A
Hide Description

For patients with disease control, duration of disease control was defined as the time from afatinib treatment start to disease progression (or death if the patient died before progression).

Disease control was defined as a having a complete response (CR, disappearance of all target lesions), partial response (PR, at least a 30% decrease in sum of longest diameter (LD) of target lesions, reference is baseline sum LD), or stable disease (SD, neither sufficient shrinkage to qualify for PR, taking as reference the baseline sum of diameters (SoD), nor sufficient increase to qualify for PD taking as reference the smallest SoD since the treatment started). Tumour response was assessed based on local radiological image (CT or MRI) evaluation by the investigators according to RECIST version 1.1. Baseline imaging was to be performed within 28 days before afatinib treatment start, if the patient already had a tumour assessment within this timeframe, this test was not repeated.
Time Frame Scans every 8 (±1) weeks from start till end of treatment. Afterwards, if discontinuation was not for progression: every 8 (±1) weeks until month 6, every 12 (±2) weeks thereafter. Until documented disease progression, i.e., up to ~ 20 Months.
Hide Outcome Measure Data
Hide Analysis Population Description
The treated set (TS) included all patients who took at least 1 afatinib dose. The aim of the study was to investigate patients with ERBB-deregulated tumours (cohort A), patients with EGFR amplification (cohort B) were therefore not included in the endpoint.
Arm/Group Title Cohort A
Hide Arm/Group Description:
Afatinib monotherapy in patients with urothelial tract carcinoma who progressed after first line of platinum-based chemotherapy and who show mutations in ERBB2 or ERBB3 or amplification in ERBB2 (Erythroblastic leukaemia viral oncogene homolog of the human epidermal growth factor family of receptors). Therapy consists of 40 mg film-coated tablets taken orally once a day continuously. The dose could be reduced to 30 mg or, in a second step, to 20 mg once daily. No dose increase was allowed after a dose reduction.
Overall Number of Participants Analyzed 34
Median (95% Confidence Interval)
Unit of Measure: Weeks
22.7
(15.1 to 36.1)
7.Secondary Outcome
Title Number of Patients With Tumour Shrinkage in Cohort A
Hide Description Number of patients with tumour shrinkage, tumour shrinkage from baseline was defined by the maximum percentage decrease from baseline in the sum of the longest diameters of target lesions. Tumour response was assessed based on local radiological image (Computerised tomography (CT) or Magnetic resonance imaging (MRI)) evaluation by the investigators according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1. Baseline imaging was to be performed within 28 days before afatinib treatment start, if the patient already had a tumour assessment within this timeframe, this test was not repeated.
Time Frame Scans every 8 (±1) weeks from start till end of treatment. Afterwards, if discontinuation was not for progression: every 8 (±1) weeks until month 6, every 12 (±2) weeks thereafter. Until documented disease progression, i.e., up to ~ 20 Months.
Hide Outcome Measure Data
Hide Analysis Population Description
The treated set (TS) included all patients who took at least 1 afatinib dose. The aim of the study was to investigate patients with ERBB-deregulated tumours (cohort A), patients with EGFR amplification (cohort B) were therefore not included in the endpoint.
Arm/Group Title Cohort A
Hide Arm/Group Description:
Afatinib monotherapy in patients with urothelial tract carcinoma who progressed after first line of platinum-based chemotherapy and who show mutations in ERBB2 or ERBB3 or amplification in ERBB2 (Erythroblastic leukaemia viral oncogene homolog of the human epidermal growth factor family of receptors). Therapy consists of 40 mg film-coated tablets taken orally once a day continuously. The dose could be reduced to 30 mg or, in a second step, to 20 mg once daily. No dose increase was allowed after a dose reduction.
Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
Patients with Shrinkage
9
  26.5%
Time Frame From the time of first drug administration till the end of treatment + 30 days (REP), up to approximately 20 Months.
Adverse Event Reporting Description The treated set (TS) included all patients who took at least 1 afatinib dose.
 
Arm/Group Title Cohort A Cohort B
Hide Arm/Group Description Afatinib monotherapy in patients with urothelial tract carcinoma who progressed after first line of platinum-based chemotherapy and who show mutations in ERBB2 or ERBB3 or amplification in ERBB2 (Erythroblastic leukaemia viral oncogene homolog of the human epidermal growth factor family of receptors). Therapy consists of 40 mg film-coated tablets taken orally once a day continuously. The dose could be reduced to 30 mg or, in a second step, to 20 mg once daily. No dose increase was allowed after a dose reduction. Afatinib monotherapy in patients with urothelial tract carcinoma who progressed after first line of platinum-based chemotherapy and who show EGFR (Epidermal Growth Factor Receptor) amplification. Therapy consists of 40 mg film-coated tablets taken orally once a day continuously. The dose could be reduced to 30 mg or, in a second step, to 20 mg once daily. No dose increase was allowed after a dose reduction.
All-Cause Mortality
Cohort A Cohort B
Affected / at Risk (%) Affected / at Risk (%)
Total   26/34 (76.47%)   7/8 (87.50%) 
Hide Serious Adverse Events
Cohort A Cohort B
Affected / at Risk (%) Affected / at Risk (%)
Total   15/34 (44.12%)   6/8 (75.00%) 
Blood and lymphatic system disorders     
Anaemia † 1  1/34 (2.94%)  0/8 (0.00%) 
Cardiac disorders     
Acute coronary syndrome † 1  0/34 (0.00%)  1/8 (12.50%) 
Cardiac failure † 1  0/34 (0.00%)  1/8 (12.50%) 
Gastrointestinal disorders     
Diarrhoea † 1  4/34 (11.76%)  2/8 (25.00%) 
Dysphagia † 1  1/34 (2.94%)  0/8 (0.00%) 
Intestinal obstruction † 1  0/34 (0.00%)  1/8 (12.50%) 
Nausea † 1  1/34 (2.94%)  0/8 (0.00%) 
Vomiting † 1  1/34 (2.94%)  0/8 (0.00%) 
General disorders     
Asthenia † 1  1/34 (2.94%)  0/8 (0.00%) 
Pain † 1  1/34 (2.94%)  0/8 (0.00%) 
Pyrexia † 1  1/34 (2.94%)  1/8 (12.50%) 
Infections and infestations     
Escherichia pyelonephritis † 1  1/34 (2.94%)  0/8 (0.00%) 
Infected skin ulcer † 1  1/34 (2.94%)  0/8 (0.00%) 
Influenza † 1  1/34 (2.94%)  0/8 (0.00%) 
Pelvic abscess † 1  1/34 (2.94%)  0/8 (0.00%) 
Respiratory tract infection † 1  0/34 (0.00%)  1/8 (12.50%) 
Urinary tract infection † 1  4/34 (11.76%)  1/8 (12.50%) 
Urinary tract infection bacterial † 1  1/34 (2.94%)  0/8 (0.00%) 
Metabolism and nutrition disorders     
Cachexia † 1  1/34 (2.94%)  0/8 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain † 1  1/34 (2.94%)  0/8 (0.00%) 
Fistula † 1  1/34 (2.94%)  0/8 (0.00%) 
Groin pain † 1  0/34 (0.00%)  1/8 (12.50%) 
Musculoskeletal disorder † 1  1/34 (2.94%)  0/8 (0.00%) 
Osteonecrosis of jaw † 1  1/34 (2.94%)  0/8 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma † 1  1/34 (2.94%)  1/8 (12.50%) 
Nervous system disorders     
Ischaemic stroke † 1  1/34 (2.94%)  0/8 (0.00%) 
Sciatica † 1  0/34 (0.00%)  1/8 (12.50%) 
Renal and urinary disorders     
Acute kidney injury † 1  1/34 (2.94%)  1/8 (12.50%) 
Renal failure † 1  1/34 (2.94%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism † 1  1/34 (2.94%)  0/8 (0.00%) 
1
Term from vocabulary, MedDRA 22.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort A Cohort B
Affected / at Risk (%) Affected / at Risk (%)
Total   34/34 (100.00%)   8/8 (100.00%) 
Blood and lymphatic system disorders     
Anaemia † 1  10/34 (29.41%)  2/8 (25.00%) 
Gastrointestinal disorders     
Abdominal pain † 1  2/34 (5.88%)  0/8 (0.00%) 
Constipation † 1  10/34 (29.41%)  1/8 (12.50%) 
Diarrhoea † 1  23/34 (67.65%)  5/8 (62.50%) 
Dry mouth † 1  1/34 (2.94%)  1/8 (12.50%) 
Dyspepsia † 1  3/34 (8.82%)  0/8 (0.00%) 
Faeces soft † 1  0/34 (0.00%)  1/8 (12.50%) 
Glossitis † 1  0/34 (0.00%)  1/8 (12.50%) 
Nausea † 1  9/34 (26.47%)  1/8 (12.50%) 
Stomatitis † 1  9/34 (26.47%)  2/8 (25.00%) 
Vomiting † 1  7/34 (20.59%)  1/8 (12.50%) 
General disorders     
Asthenia † 1  19/34 (55.88%)  3/8 (37.50%) 
Malaise † 1  1/34 (2.94%)  1/8 (12.50%) 
Mucosal inflammation † 1  10/34 (29.41%)  3/8 (37.50%) 
Oedema peripheral † 1  2/34 (5.88%)  1/8 (12.50%) 
Pain † 1  3/34 (8.82%)  1/8 (12.50%) 
Pyrexia † 1  7/34 (20.59%)  1/8 (12.50%) 
Xerosis † 1  3/34 (8.82%)  1/8 (12.50%) 
Infections and infestations     
Clostridium difficile infection † 1  0/34 (0.00%)  1/8 (12.50%) 
Folliculitis † 1  1/34 (2.94%)  1/8 (12.50%) 
Paronychia † 1  3/34 (8.82%)  3/8 (37.50%) 
Respiratory tract infection † 1  2/34 (5.88%)  0/8 (0.00%) 
Skin candida † 1  0/34 (0.00%)  1/8 (12.50%) 
Urinary tract infection † 1  6/34 (17.65%)  3/8 (37.50%) 
Injury, poisoning and procedural complications     
Fall † 1  2/34 (5.88%)  0/8 (0.00%) 
Investigations     
Alanine aminotransferase increased † 1  0/34 (0.00%)  2/8 (25.00%) 
Aspartate aminotransferase increased † 1  0/34 (0.00%)  1/8 (12.50%) 
Blood creatine phosphokinase increased † 1  2/34 (5.88%)  0/8 (0.00%) 
Blood creatinine increased † 1  2/34 (5.88%)  1/8 (12.50%) 
Blood lactate dehydrogenase increased † 1  1/34 (2.94%)  1/8 (12.50%) 
Platelet count decreased † 1  0/34 (0.00%)  1/8 (12.50%) 
Transaminases increased † 1  0/34 (0.00%)  1/8 (12.50%) 
Weight decreased † 1  1/34 (2.94%)  1/8 (12.50%) 
Metabolism and nutrition disorders     
Cachexia † 1  2/34 (5.88%)  0/8 (0.00%) 
Decreased appetite † 1  15/34 (44.12%)  2/8 (25.00%) 
Hyperkalaemia † 1  1/34 (2.94%)  1/8 (12.50%) 
Hypoalbuminaemia † 1  0/34 (0.00%)  1/8 (12.50%) 
Hypokalaemia † 1  2/34 (5.88%)  0/8 (0.00%) 
Hypomagnesaemia † 1  4/34 (11.76%)  1/8 (12.50%) 
Hyponatraemia † 1  2/34 (5.88%)  1/8 (12.50%) 
Hypophosphataemia † 1  2/34 (5.88%)  0/8 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain † 1  7/34 (20.59%)  0/8 (0.00%) 
Bone pain † 1  2/34 (5.88%)  0/8 (0.00%) 
Pain in extremity † 1  3/34 (8.82%)  0/8 (0.00%) 
Nervous system disorders     
Dysgeusia † 1  2/34 (5.88%)  1/8 (12.50%) 
Neuropathy peripheral † 1  2/34 (5.88%)  0/8 (0.00%) 
Paraesthesia † 1  2/34 (5.88%)  0/8 (0.00%) 
Speech disorder † 1  0/34 (0.00%)  1/8 (12.50%) 
Psychiatric disorders     
Insomnia † 1  2/34 (5.88%)  1/8 (12.50%) 
Renal and urinary disorders     
Dysuria † 1  0/34 (0.00%)  1/8 (12.50%) 
Haematuria † 1  2/34 (5.88%)  0/8 (0.00%) 
Leukocyturia † 1  2/34 (5.88%)  0/8 (0.00%) 
Oliguria † 1  0/34 (0.00%)  1/8 (12.50%) 
Proteinuria † 1  2/34 (5.88%)  0/8 (0.00%) 
Renal failure † 1  3/34 (8.82%)  0/8 (0.00%) 
Reproductive system and breast disorders     
Pelvic pain † 1  2/34 (5.88%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis † 1  2/34 (5.88%)  1/8 (12.50%) 
Haemoptysis † 1  1/34 (2.94%)  1/8 (12.50%) 
Skin and subcutaneous tissue disorders     
Dermatitis † 1  2/34 (5.88%)  1/8 (12.50%) 
Dermatitis acneiform † 1  4/34 (11.76%)  1/8 (12.50%) 
Dry skin † 1  3/34 (8.82%)  1/8 (12.50%) 
Pruritus † 1  5/34 (14.71%)  2/8 (25.00%) 
Rash † 1  11/34 (32.35%)  1/8 (12.50%) 
Skin erosion † 1  0/34 (0.00%)  1/8 (12.50%) 
Skin lesion † 1  2/34 (5.88%)  1/8 (12.50%) 
Skin toxicity † 1  4/34 (11.76%)  1/8 (12.50%) 
Vascular disorders     
Hypotension † 1  2/34 (5.88%)  0/8 (0.00%) 
1
Term from vocabulary, MedDRA 22.0
†
Indicates events were collected by systematic assessment
Duration of confirmed objective response was not analysed because only 2 patients showed a confirmed objective response. Instead, duration of disease control was analysed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02780687    
Other Study ID Numbers: 1200.261
2015-005427-10 ( EudraCT Number )
First Submitted: May 20, 2016
First Posted: May 23, 2016
Results First Submitted: September 17, 2020
Results First Posted: October 12, 2020
Last Update Posted: November 18, 2020